K252322
- 510(k) number
- K252322
- Device name
- SIros-X System
- Applicant
- Genesys Spine TX · US
- Product code
- OUR — Sacroiliac Joint Fixation
- Decision date
- 2025-10-22
- Date received
- 2025-07-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K252322.pdf
Official FDA record: K252322
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.